Fresh Recalls

FDAClass II · Medical device · Recall Z-3045-2026 · Recalled September 9, 2026

1) NEURO recall — AVID Medical, Inc.

Agency report date: September 9, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
1) NEURO
Company / brand
AVID Medical
Lot / serial / date codes
Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649716; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1666559; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649717; Model/Item Number (kit) ACNE73-03, UDI/DI 10809160513996, Kit Lot Number 1696563; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1650945; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666564; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1664544; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666978; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1685117; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688043; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688044; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1666733; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1659950; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160457634, Kit Lot Number 1649141; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160404430, Kit Lot Number 1606455; Model/Item Number (kit) DGNE75, UDI/DI 10809160468104, Kit Lot Number 1659330; Model/Item Number (kit) DGNE75-02, UDI/DI 10809160510001, Kit Lot Number 1688056; Model/Item Number (kit) DRNE75, UDI/DI 10809160467190, Kit Lot Number 1658535; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1681499; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1691081; Model/Item Number (kit) DUCR36-01, UDI/DI 10809160497388, Kit Lot Number 1675499; Model/Item Number (kit) DUCR36-02, UDI/DI 10809160513538, Kit Lot Number 1691089; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1675518; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686203; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686204; Model/Item Number (kit) DUNE88-01, UDI/DI 10809160498217, Kit Lot Number 1675520; Model/Item Number (kit) DUSP98-01, UDI/DI 10809160497708, Kit Lot Number 1680111; Model/Item Number (kit) DUSP98-02, UDI/DI 10809160513392, Kit Lot Number 1691105; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 1633353; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1694281; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1691158; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 374076; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1648983; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1646886; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1649731; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1633403; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669417; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1678530; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1670304; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1691551; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669415; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1680385; Model/Item Number (kit) EURO009-09, UDI/DI 10809160414217, Kit Lot Number 1649363; Model/Item Number (kit) IHCR36-01, UDI/DI 10809160477557, Kit Lot Number 344863; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343178; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343377; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343179; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348826; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348828; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348829; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348830; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348834; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348835; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664733; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1656356; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1667191; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 838447; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664206; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664732; Model/Item Number (kit) MAMC275-06, UDI/DI 10809160421666, Kit Lot Number 1644895; Model/Item Number (kit) MAMC275-07, UDI/DI 10809160495902, Kit Lot Number 1675387; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1652837; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633247; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633983; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670241; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1636102; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633985; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670240; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1697302; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1674543; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670238; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1680358; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1691128; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1700133; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1658933; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1694755; Model/Item Number (kit) MECP05R, UDI/DI 10809160417331, Kit Lot Number 1671174; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1632022; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1628605; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651140; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651139; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651141; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651142; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1671525; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652669; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1654982; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652667; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652668; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1646454; Model/Item Number (kit) MHCP75-01, UDI/DI 10809160479568, Kit Lot Number 345849; Model/Item Number (kit) MMOK007-03, UDI/DI 10809160460764, Kit Lot Number 1696427; Model/Item Number (kit) MMTN012-04, UDI/DI 10809160444085, Kit Lot Number 1644099; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623100; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1650608; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623102; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1639185; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1657124; Model/Item Number (kit) NAMC413-07, UDI/DI 10809160374306, Kit Lot Number 1652550; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1629049; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1656868; Model/Item Number (kit) NAMC434-08, UDI/DI 10809160417584, Kit Lot Number 1649106; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1681967; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1656161; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1688028; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1675548; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1664880; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1684189; Model/Item Number (kit) OSCR20-01, UDI/DI 10809160436370, Kit Lot Number 1664480; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658194; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658423; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658192; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1691893; Model/Item Number (kit) RDLD008-14, UDI/DI 10809160467367, Kit Lot Number 1658206; Model/Item Number (kit) SAMM031-18, UDI/DI 10809160494363, Kit Lot Number 1672515; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1651950; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1652543; Model/Item Number (kit) SGAC31-02, UDI/DI 10809160469491, Kit Lot Number 1661052; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667346; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1673274; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667347; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1668002; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1691061; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1700807; Model/Item Number (kit) SGSP11, UDI/DI 10809160461730, Kit Lot Number 1656113; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668007; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1691439; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668009; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668008; Model/Item Number (kit) SGSP44-02, UDI/DI 10809160469620, Kit Lot Number 1661236; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668013; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1676432; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668011; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668014; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1667304; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668012; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1656747; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1653016; Model/Item Number (kit) SGSP91-02, UDI/DI 10809160469644, Kit Lot Number 1661240; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671768; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671769; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1667616; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673361; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673362; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1691066; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1574836; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1579673; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1582963; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1588397; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1589834; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1590905; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603715; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1610818; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1655825; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1609281; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603716; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1648191; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1653849; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1611976; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1622358; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1617996; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1660322; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1665018; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1680232; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1691224; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1566522; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1568213; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1612999; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1613422; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1644462; Model/Item Number (kit) SLCN72-01, UDI/DI 10809160446416, Kit Lot Number 1636631; Model/Item Number (kit) SLCN72-02, UDI/DI 10809160457030, Kit Lot Number 1647141; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1667104; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662160; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662162; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1668135; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1691204; Model/Item Number (kit) UDCP57-01, UDI/DI 10809160483404, Kit Lot Number 345399; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664831; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664832; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1669219; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1680592; Model/Item Number (kit) VAML012-07, UDI/DI 10809160379011, Kit Lot Number 1612231; Model/Item Number (kit) VAML028-06, UDI/DI 10809160379127, Kit Lot Number 1626107; Model/Item Number (kit) VAPX009-02, UDI/DI 10809160302491, Kit Lot Number 1694165; Model/Item Number (kit) VMCC024-14, UDI/DI 10809160458891, Kit Lot Number 1653475; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663908; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663979; Model/Item Number (kit) WEAC53-01, UDI/DI 10809160485347, Kit Lot Number 349078; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348573; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348575; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348673; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 344499; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348358; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348360; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348364; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348402; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348409; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1652912; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1660282; Model/Item Number (kit) WKMC125-03, UDI/DI 10809160448113, Kit Lot Number 1641373; Model/Item Number (kit) WRNM030-21, UDI/DI 10809160441961, Kit Lot Number 1661529.
Distribution
US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
Agency product description and boundaries

1) NEURO, (kit) ACNE73-01; 2) NEURO, (kit) ACNE73-03; 3) CRANI, (kit) AKCR19-01; 4) ORTHO SPINE PACK, (kit) ARMC017; 5) BMHM NEURO PACK, (kit) BMHT016-05; 6) LUMBAR PACK, (kit) BMHT112-03; 7) NEURO LAMINECTOMY PACK, (kit) DGNE75; 8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02; 9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75; 10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01; 11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01; 12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02; 13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01; 14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01; 15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01; 16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02; 17) CRANI PACK 712638, (kit) EFCR86-01; 18) SPINE PACK 712040, (kit) EFSP30-01; 19) SPINE PACK 712040, (kit) EFSP30-02; 20) CRANIOTOMY TRAY, (kit) EURO009-09; 21) CRANI PACK, (kit) IHCR36-01; 22) NEURO PACK, (kit) IHNE35-01; 23) CRANIOTOMY PACK, (kit) JACK410-11; 24) BASIC NEURO PACK, (kit) MAMC275-06; 25) BASIC NEURO PACK, (kit) MAMC275-07; 26) SPINE CRANI PACK, (kit) MCSP92-01; 27) CRANIOTOMY PACK, (kit) MECP05R; 28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02; 29) NEURO BASIC PACK, (kit) MENE06T; 30) CRANIAL PACK - 205992, (kit) MHCP75-01; 31) NEURO PACK, (kit) MMOK007-03; 32) NEURO PACK, (kit) MMTN012-04; 33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01; 34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07; 35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05; 36) NEURO CRANI ADD A PACK, (kit) NAMC434-08; 37) NEURO PACK, (kit) NWHR010-03; 38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01; 39) NEURO PACK, (kit) RDLD001-14; 40) CRANI PACK, (kit) RDLD008-14; 41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18; 42) CRANIOTOMY PACK, (kit) SELF111-02; 43) PELHAM ACDF, (kit) SGAC31-02; 44) PELHAM ACDF, (kit) SGAC31-03; 45) PELHAM MINA SPINE, (kit) SGSP11; 46) PELHAM MINA SPINE, (kit) SGSP11-03; 47) PELHAM SPINE, (kit) SGSP44-02; 48) PELHAM SPINE, (kit) SGSP44-03; 49) SPINE, (kit) SGSP91; 50) SPINE, (kit) SGSP91-02; 51) SPINE, (kit) SGSP91-03; 52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02; 53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15; 54) CRANI PACK, (kit) SLCN72-01; 55) CRANI PACK, (kit) SLCN72-02; 56) CRANI PACK, (kit) SLCN72-03; 57) CRANI PACK - 208400, (kit) UDCP57-01; 58) NEURO TRAY-LF, (kit) UMIA104-11; 59) CRANIOTOMY PACK, (kit) USMA005; 60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07; 61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06; 62) NASAL SINUS, (kit) VAPX009-02; 63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14; 64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05; 65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01; 66) CRANI PACK, (kit) WECR41-01; 67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01; 68) LUMBAR LAMINECTOMY, (kit) WKMC114-03; 69) CRANIOTOMY PK, (kit) WKMC125-03; 70) DISKECTOMY PACK, (kit) WRNM030-21.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: 1) NEURO recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-3045-2026
Brand
All AVID Medical recalls
Classification
Class II
Units affected
16223 kits
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Toano, VA, United States
Firm address
9000 Westmont Dr, N/A, 23168-9351

Identifying details (verbatim from the notice)

Product codes / lots
Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649716; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1666559; Model/Item Number (kit) ACNE73-01, UDI/DI 10809160458532, Kit Lot Number 1649717; Model/Item Number (kit) ACNE73-03, UDI/DI 10809160513996, Kit Lot Number 1696563; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1650945; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666564; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1664544; Model/Item Number (kit) AKCR19-01, UDI/DI 10809160459515, Kit Lot Number 1666978; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1685117; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688043; Model/Item Number (kit) ARMC017, UDI/DI 10809160506455, Kit Lot Number 1688044; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1666733; Model/Item Number (kit) BMHT016-05, UDI/DI 10809160468821, Kit Lot Number 1659950; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160457634, Kit Lot Number 1649141; Model/Item Number (kit) BMHT112-03, UDI/DI 10809160404430, Kit Lot Number 1606455; Model/Item Number (kit) DGNE75, UDI/DI 10809160468104, Kit Lot Number 1659330; Model/Item Number (kit) DGNE75-02, UDI/DI 10809160510001, Kit Lot Number 1688056; Model/Item Number (kit) DRNE75, UDI/DI 10809160467190, Kit Lot Number 1658535; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1681499; Model/Item Number (kit) DRNE75-01, UDI/DI 10809160503843, Kit Lot Number 1691081; Model/Item Number (kit) DUCR36-01, UDI/DI 10809160497388, Kit Lot Number 1675499; Model/Item Number (kit) DUCR36-02, UDI/DI 10809160513538, Kit Lot Number 1691089; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1675518; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686203; Model/Item Number (kit) DUNC42-01, UDI/DI 10809160497524, Kit Lot Number 1686204; Model/Item Number (kit) DUNE88-01, UDI/DI 10809160498217, Kit Lot Number 1675520; Model/Item Number (kit) DUSP98-01, UDI/DI 10809160497708, Kit Lot Number 1680111; Model/Item Number (kit) DUSP98-02, UDI/DI 10809160513392, Kit Lot Number 1691105; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 1633353; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1694281; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160456026, Kit Lot Number 1691158; Model/Item Number (kit) EFCR86-01, UDI/DI 10809160442210, Kit Lot Number 374076; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1648983; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1646886; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1649731; Model/Item Number (kit) EFSP30-01, UDI/DI 10809160456187, Kit Lot Number 1633403; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669417; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1678530; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1670304; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1691551; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1669415; Model/Item Number (kit) EFSP30-02, UDI/DI 10809160492024, Kit Lot Number 1680385; Model/Item Number (kit) EURO009-09, UDI/DI 10809160414217, Kit Lot Number 1649363; Model/Item Number (kit) IHCR36-01, UDI/DI 10809160477557, Kit Lot Number 344863; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343178; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343377; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 343179; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348826; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348828; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348829; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348830; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348834; Model/Item Number (kit) IHNE35-01, UDI/DI 10809160477724, Kit Lot Number 348835; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664733; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1656356; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1667191; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 838447; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664206; Model/Item Number (kit) JACK410-11, UDI/DI 10809160464991, Kit Lot Number 1664732; Model/Item Number (kit) MAMC275-06, UDI/DI 10809160421666, Kit Lot Number 1644895; Model/Item Number (kit) MAMC275-07, UDI/DI 10809160495902, Kit Lot Number 1675387; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1652837; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633247; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633983; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670241; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1636102; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160442999, Kit Lot Number 1633985; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670240; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1697302; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1674543; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1670238; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1680358; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160453124, Kit Lot Number 1691128; Model/Item Number (kit) MCSP92-01, UDI/DI 10809160514719, Kit Lot Number 1700133; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1658933; Model/Item Number (kit) MECP05R, UDI/DI 10809160418109, Kit Lot Number 1694755; Model/Item Number (kit) MECP05R, UDI/DI 10809160417331, Kit Lot Number 1671174; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1632022; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160382912, Kit Lot Number 1628605; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651140; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651139; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651141; Model/Item Number (kit) MEDF217-02, UDI/DI 10809160459706, Kit Lot Number 1651142; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1671525; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652669; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1654982; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652667; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1652668; Model/Item Number (kit) MENE06T, UDI/DI 10809160461327, Kit Lot Number 1646454; Model/Item Number (kit) MHCP75-01, UDI/DI 10809160479568, Kit Lot Number 345849; Model/Item Number (kit) MMOK007-03, UDI/DI 10809160460764, Kit Lot Number 1696427; Model/Item Number (kit) MMTN012-04, UDI/DI 10809160444085, Kit Lot Number 1644099; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623100; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1650608; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1623102; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1639185; Model/Item Number (kit) MSMC108-01, UDI/DI 10809160427972, Kit Lot Number 1657124; Model/Item Number (kit) NAMC413-07, UDI/DI 10809160374306, Kit Lot Number 1652550; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1629049; Model/Item Number (kit) NAMC433-05, UDI/DI 10809160417584, Kit Lot Number 1656868; Model/Item Number (kit) NAMC434-08, UDI/DI 10809160417584, Kit Lot Number 1649106; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1681967; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1656161; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1688028; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1675548; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1664880; Model/Item Number (kit) NWHR010-03, UDI/DI 10809160456637, Kit Lot Number 1684189; Model/Item Number (kit) OSCR20-01, UDI/DI 10809160436370, Kit Lot Number 1664480; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658194; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658423; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1658192; Model/Item Number (kit) RDLD001-14, UDI/DI 10809160467374, Kit Lot Number 1691893; Model/Item Number (kit) RDLD008-14, UDI/DI 10809160467367, Kit Lot Number 1658206; Model/Item Number (kit) SAMM031-18, UDI/DI 10809160494363, Kit Lot Number 1672515; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1651950; Model/Item Number (kit) SELF111-02, UDI/DI 10809160458808, Kit Lot Number 1652543; Model/Item Number (kit) SGAC31-02, UDI/DI 10809160469491, Kit Lot Number 1661052; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667346; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1673274; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1667347; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1668002; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1691061; Model/Item Number (kit) SGAC31-03, UDI/DI 10809160489437, Kit Lot Number 1700807; Model/Item Number (kit) SGSP11, UDI/DI 10809160461730, Kit Lot Number 1656113; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668007; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1691439; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668009; Model/Item Number (kit) SGSP11-03, UDI/DI 10809160511145, Kit Lot Number 1668008; Model/Item Number (kit) SGSP44-02, UDI/DI 10809160469620, Kit Lot Number 1661236; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668013; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1676432; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668011; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668014; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1667304; Model/Item Number (kit) SGSP44-03, UDI/DI 10809160490037, Kit Lot Number 1668012; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1656747; Model/Item Number (kit) SGSP91, UDI/DI 10809160462102, Kit Lot Number 1653016; Model/Item Number (kit) SGSP91-02, UDI/DI 10809160469644, Kit Lot Number 1661240; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671768; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1671769; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1667616; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673361; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1673362; Model/Item Number (kit) SGSP91-03, UDI/DI 10809160511558, Kit Lot Number 1691066; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1574836; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1579673; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1582963; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1588397; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1589834; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1590905; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603715; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1610818; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1655825; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1609281; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1603716; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1648191; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1653849; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1611976; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1622358; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1617996; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1660322; Model/Item Number (kit) SHND416-02, UDI/DI 10809160363539, Kit Lot Number 1665018; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1680232; Model/Item Number (kit) SHND416-02, UDI/DI 10809160502297, Kit Lot Number 1691224; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1566522; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160390498, Kit Lot Number 1568213; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1612999; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1613422; Model/Item Number (kit) SHOR003-15, UDI/DI 10809160411513, Kit Lot Number 1644462; Model/Item Number (kit) SLCN72-01, UDI/DI 10809160446416, Kit Lot Number 1636631; Model/Item Number (kit) SLCN72-02, UDI/DI 10809160457030, Kit Lot Number 1647141; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1667104; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662160; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1662162; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1668135; Model/Item Number (kit) SLCN72-03, UDI/DI 10809160470701, Kit Lot Number 1691204; Model/Item Number (kit) UDCP57-01, UDI/DI 10809160483404, Kit Lot Number 345399; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664831; Model/Item Number (kit) UMIA104-11, UDI/DI 10809160465189, Kit Lot Number 1664832; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1669219; Model/Item Number (kit) USMA005, UDI/DI 10809160388297, Kit Lot Number 1680592; Model/Item Number (kit) VAML012-07, UDI/DI 10809160379011, Kit Lot Number 1612231; Model/Item Number (kit) VAML028-06, UDI/DI 10809160379127, Kit Lot Number 1626107; Model/Item Number (kit) VAPX009-02, UDI/DI 10809160302491, Kit Lot Number 1694165; Model/Item Number (kit) VMCC024-14, UDI/DI 10809160458891, Kit Lot Number 1653475; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663908; Model/Item Number (kit) VMED009-05, UDI/DI 10809160487808, Kit Lot Number 1663979; Model/Item Number (kit) WEAC53-01, UDI/DI 10809160485347, Kit Lot Number 349078; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348573; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348575; Model/Item Number (kit) WECR41-01, UDI/DI 10809160485392, Kit Lot Number 348673; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 344499; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348358; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348360; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348364; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348402; Model/Item Number (kit) WELL73-01, UDI/DI 10809160485545, Kit Lot Number 348409; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1652912; Model/Item Number (kit) WKMC114-03, UDI/DI 10809160448069, Kit Lot Number 1660282; Model/Item Number (kit) WKMC125-03, UDI/DI 10809160448113, Kit Lot Number 1641373; Model/Item Number (kit) WRNM030-21, UDI/DI 10809160441961, Kit Lot Number 1661529.
Distribution
US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.
Firm notified the public via
E-Mail
FDA event ID
99469
Recall initiated
May 19, 2026
FDA classified
August 28, 2026
FDA report date
September 9, 2026

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

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